Senior Regulatory Medical Writer Position

1 day ago

Sydney, New South Wales, Australia beBeeMedicalWriter Full time $100,000 - $140,000
Regulatory Medical Writer II

This is a senior-level position that involves coordination, writing and editing of various clinical study documents. The ideal candidate will have extensive experience in preparing Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), Clinical Study Reports (CSRs) and other clinical trial documents.

Responsibilities
  • Clinical Document Preparation: This includes the coordination, writing and editing of IBs, CSPs, PICFs and CSRs.
  • Techincal Support: Providing technical support to other departments and clients, including mentoring junior medical writers and maintaining quality processes.
Requirements
  • Qualifications: A degree in a scientific or relevant discipline. A higher degree is desirable.
  • Experience: Minimum 2 years of experience as a Medical Writer with prior experience in preparing IBs, CSPs, PICFs and CSRs. Minimum 3 years of experience in the biotechnology/pharmaceutical/clinical research industry.
  • Skills: Strong research report writing skills and/or demonstrated experience in writing peer-reviewed journal articles. Knowledge of ICH GCP guideline, ICH E3 guideline, medical terminology and clinical trials processes.
About the Role

This role offers an exciting opportunity for experienced medical writers to leverage their expertise in regulatory document preparation and technical support. If you are looking for a challenging and rewarding career path, this may be the ideal opportunity for you.

We are seeking highly motivated and organized individuals who can work effectively in a fast-paced environment. If you have a passion for clinical research and regulatory affairs, we encourage you to apply for this position.

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